Research Analytics

We provide our researchers and clinical trials investigators with the information, data management, analysis and statistical interpretations they need. Our team protects the privacy and personal details of people participating in research and clinical trials.

Overview

Data Management & Analysis: Research Advantage

Our team of data management specialists, analysts, programmers and biostatisticians supports the information and analysis needs of researchers throughout Aurora Health Care.

We have three main areas of responsibility:

Data management: We manage the systems that track people participating in clinical trials. Our oversight ensures patient safety and privacy and project compliance with regulations.

Analysis and interpretation: Analysts and biostatisticians analyze and interpret data from research and clinical trials.

Management

Data Systems Expertise

Our systems specialists administer the databases where we keep and access clinical trial information. Over time, we update participants’ electronic health records to include information about the clinical trials in which they are participating.

Clinical Trial Management System (CTMS)

In our CTMS, we store all the information related to clinical trials at Aurora. This system allows us to track:

Participation: We know who’s enrolled in which clinical trial at any time. Having secure and accurate information about participation helps us effectively analyze trial results and evaluate their benefits.

Billable event: Our system makes sure we correctly bill insurance or clinical trial sponsors for the products and services associated with trials.

Safety: Patient safety is our utmost concern. Along with the doctors conducting a trial, we track patients’ health to make sure we spot adverse reactions or medical problems that may indicate a safety risk.

Protocol compliance: To carry out clinical trials and give our patients access to experimental treatments, we must comply with all regulations and protocols. We help researchers monitor their compliance with these rules.

Providing Valuable Information From Electronic Health Records

Electronic health records store people’s health histories so physicians can understand their patients more fully and make the best treatment choices.

For researchers and physicians running clinical trials, these records are important for choosing suitable candidates and evaluating health outcomes after the trial.

Our team is responsible for:

Updates: Physicians need to know when their patients are participating in clinical trials for drug interaction and treatment safety reasons. We work with clinical trial coordinators to keep participants’ records consistently up to date.

Recruitment: We can provide reports to clinical trial coordinators that identify potential candidates for clinical trials based on their health and treatment history. The coordinator will confirm if the patient may be a good candidate. If so, the coordinator will suggest a physician or another clinician inform that person of an upcoming trial and ask if he or she is interested in participating.

Consent: We track consent information to ensure compliance with the regulations.

Follow-up data: Our up-to-date system of participants in clinical trials allows researchers to contact people for follow-up evaluations or to recommend another trial for a particular participant.

RAPID Program

Under state and federal law, we may use, keep and share for our research purposes "de-identified" health information, which is not considered private information because it does not identify you. Our research data warehouse stores health information that can be tracked back to the patient to whom it pertains only through a code; and access to the code is restricted to specified and specially trained Aurora caregivers who do not have any responsibility for research or patient care.

De-identified health information is used by Aurora researchers to study disease and treatments, and may be shared with other approved users of the research data warehouse to develop new research proposals, treatments or commercial products. Using this tool, we hope to improve our ability to offer patients the opportunity to participate in clinical trials if they wish, and to improve long-term analyses that may help to improve the effectiveness and safety of health care.

If you do not want your de-identified research information to be included in our RAPID program, you must contact us toll-free at 855-229-0926. We will stop including your de-identified information, but we will not be able to remove your de-identified information that has already been included.

Information Retrieval

Retrieving the Information Researchers Need

The data requests we support for retrospective research studies are varied and complex. In a translational research model, researchers often need to do a retrospective study before ultimately conducting a clinical trial.

Our team of business system analysts and programmers specializes in getting the relevant information for researchers. We can extract relevant information from electronic health records without compromising patient privacy.

We can help you with:

Feasibility: The first thing researchers need to know is if there are enough candidates to carry out a meaningful clinical trial or project. We can estimate the number of people who meet the criteria of the study within our health care system. This saves time and money for researchers.

Eligibility: We can assist with eligibility reports and provide researchers with a detailed list of eligible candidates who fulfill research criteria.

Recruitment: Our clinical trial coordinators set up pathways to approach eligible candidates for trial. Typically, coordinators inform physicians they may have eligible patients for a trial. The physicians talk to their patients about participating in a trial that may help them. If patients are interested, they are put in touch with the relevant trial.

Biostatistics

Analyzing & Interpreting Data & Outcomes

Our biostatisticians, often working with our business analysts and programmers, can analyze and interpret raw data and clinical outcomes.

We help quantify benefits, risks and expected outcomes. When it comes to research validity, this precise knowledge helps researchers and clinicians evaluate the impact of a drug or device.

We provide support with:

Study design: Our biostatisticians help researchers design a statistical plan to answer their research question. This plan describes analysis objectives, populations and subgroups (treatment and control groups), endpoints and procedures. Having a statistical plan helps researchers interpret outcomes.

Interpretation: We can analyze data from a clinical trial or research project and help interpret what it means. Biostatisticians have the statistical expertise, and investigators typically have the clinical expertise.

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